A closely watched trial that many hoped would help clarify a contentious battle over access to generic drugs instead ended in disappointment last week. In fact, the outcome only seems to have underscored the difficulty in sorting out so-called pay-to-delay deals, a topic that has embroiled the pharmaceutical industry, regulators and the courts for years.

In these arrangements, a brand-name drug maker and a generic rival locked in patent litigation reach a settlement. The brand-name drug maker may offer cash or something else of value and, in return, wins more time to sell its medicine without encountering lower-cost competition. The generic drug maker, meanwhile, also comes away with an agreement to sell its copycat medicine at a specified future date.

Such maneuvering has raised antitrust concerns at the U.S. Federal Trade Commission, which has estimated these deals cost Americans $3.5 billion annually in higher health-care costs. For its part, the pharmaceutical industry contends the deals aren't only legal, but allow lower-cost generic drugs to reach consumers faster than if patent litigation dragged on.

The issue bubbled up to the U.S. Supreme Court, which last year ruled such deals can face greater antitrust scrutiny. The case decided last week—in which
AstraZeneca
PLC and
Ranbaxy Laboratories Ltd.
were accused of illegally delaying a generic version of AstraZeneca’s Nexium heartburn pill—offered the prospect of some much-needed clarity since it was the first to go to trial since the ruling.

Instead, the federal court jury in Boston offered a mixed bag. On one hand, the jury decided the drug makers failed key litmus tests established by the Supreme Court ruling. AstraZeneca offered Ranbaxy deals that several wholesalers and pharmacies argued in their lawsuit were worth up to $1 billion.

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Pharmalot is a WSJ blog exploring how medicines are made and marketed, at WSJ.com/Pharmalot.

One involved a commitment made by AstraZeneca not to sell a so-called authorized generic Nexium, which is a lower-cost version of its own drug. This had value because Ranbaxy would have had less competition, and the jury agreed this was anticompetitive and “large and unjustified.” The other deal had Ranbaxy supply and distribute ingredients for some AstraZeneca drugs.

But AstraZeneca prevailed because the jury decided there was no harm done. How so? The drug makers had agreed that a generic version of Nexium wouldn't become available before May 2014 and there was no evidence this would have happened earlier had there not been a settlement. In other words, the jury didn't find reason to believe Ranbaxy would have sold a pill any sooner.

“The Nexium case sends a clear signal that pay-for-delay claims are much easier to allege than prove at trial.” says Jay Lefkowitz, an attorney at Kirkland & Ellis who represents brand-name drug makers.

Maybe so. But there was an extenuating circumstance that is unlikely to emerge in other cases. In this instance, Ranbaxy was unable to sell a generic Nexium sooner than May 2014 because of manufacturing problems that prompted the FDA to ban products made at certain facilities.

“The plaintiffs did enough to prove their case,” says Michael Carrier, a Rutgers University School of Law professor who specializes in intellectual-property issues and has filed a brief in another pay-to-delay case on behalf of consumer groups. “It just came down to one thing—the generic company was not ready to launch before 2014.”

One issue in this case does factor into how others may be decided – whether antitrust law is violated only if cash is exchanged between a brand-name drug maker and its generic rival. Although AstraZeneca also agreed not to sell an authorized generic Nexium, the case did not turn on whether a cash payment was the only means by which to measure antitrust activity.

Ever since the Supreme Court ruling, there has been debate about this issue and a federal appeals court is expected to be decide one such case shortly. The impact may be significant.

“If the court says there has to be cash involved [for a settlement to be considered anticompetitive], says Seth Silber, an attorney at Wilson, Sonsini, Goodrich & Rosati and a former adviser at the FTC, “pharmaceutical companies would have a lot more flexibility in how they settle cases.”

—Pharmalot is the Journal’s blog exploring how medicines are made and marketed, at WSJ.com/Pharmalot. Follow Ed Silverman @Pharmalot.